3 min reading time Australia’s “Fast Track” process – whereby 90% of medical devices are approved based on their CE marking through an expedited process – has been open to importers for more than a decade. Two weeks ago, a long campaign championed by Sydney-based regulatory affairs expert Arthur Brandwood came to fruition. The Australian Therapeutic Goods Administration (TGA) agreed to give domestic manufacturers the same access as importers. Arthur will talk about the big changes in Australian for devices on a November 18 webinar: http://medgroup.biz/TGA-changes He’ll also cover: So if you or members of your team do medical device business in Australia, join us on the call. We’ll record it and make the replay, slides, and transcript available to all who register – even if you can’t make the live event. That link again: http://medgroup.biz/TGA-changes ++++++++++ Arthur is among the presenters at The Asia-Pacific Summit for Medical Devices (March 5-6, San Diego). See http://AsiaPacificDeviceSummit.com Should you attend? Yes, if: The event brings local experts from Taipei, Singapore, Jakarta, Sydney, Kuala Lumpur, and Beijing right to you in beautiful San Diego. To get this collective knowledge and these introductions, you’d otherwise have to fly to the Asia-Pacific yourself! I’m going. See the agenda at http://AsiaPacificDeviceSummit.com ++++++++++ Discussions This Week Is a Prototype Enough? Which ERP system is a good fit for medical products? Do you think there are too many FDA regulations? Device registration in a one country to cover every country? ++++++++++ Make it a great week. Joe Hage P.S. If you do business in the Pacific, visit the http://AsiaPacificDeviceSummit.com site – it’s a new event and maybe the one you need. Sid Goel Donna Cusano Arthur Brandwood Donna Cusano Arthur Brandwood Indeed you are quite right that this was an effort of many. I would particularly like to acknowledge the efforts of the industry associations and especially AusBiotech and my colleagues on the regulatory expert panel of its medical devices division, Ausmedtech – who carried the torch on this for a long time. Arthur Arthur Brandwood Indeed it does apply to all medical devices in Australia except for the very highest risk Class III with an integral medicine or a biologic – which require a direct TGA review. Arthur (in transit in HK between China and Australia!) Joe Hage Donna Cusano Joe Hage As you note, he was heavily involved and I’m grateful he’s willing to share his knowledge with the group for free. Thank you for the correction. Mark Taffa These changes were “championed” by many companies and associations. Arthur Brandwood is well known and respected in the Australian industry and it is no surprise that he was heavily involved. Your post implies a single person “championed” the change at the TGA which is not quite correct. These changes were at the top of the regulatory agenda for industry associations and other local manufacturers. These changes are a fundamental regulatory shift for Australian manufacturers supplying our domestic market and very good news. Mark Marked as spam  Posted by Asked on November 4, 2014 11:27 am 90 views |
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